Label: OXYGEN gas

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved medical gas

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 1, 2010

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  • OXYGEN CERTIFICATE OF ANALYSIS

    SIMS WELDING SUPPLY QUALITY ASSURANCE PROGRAM VERSION 8 AUGUST 2007 PAGE 128

    8.11 CERTIFICATE OF ANALYSIS - OXYGEN USP

    CERTIFICATE OF ANALYSIS OXYGEN LIQUEFIED

    CUSTOMER____ DATE______LOT#____________INVOICE#___________________

    USP MEDICAL GRADE

    TEST/REQUIREMENT      NF SPECIFICATION      LOT ANALYSIS      ANALYTICAL METHOD

    IDENTIFICATION                  PASS                                                         PARAMAGNETISM - SERVOMEX

    ODOR                                 NO APPRECIABLE ODOR                           ORGANOLEPTIC

    CARBON DIOXIDE               LESS THAN OR EQUAL TO 0.03%  SEE NOTE      SEE NOTE

    CARBON MONOXIDE         LESS THAN OR EQUAL TO 0.001%   SEE NOTE      SEE NOTE

    ASSAY                              GREATER THAN OR EQUAL TO 99.6%            PARAMAGNETISM - SERVOMEX

    NOTE: USP/NF EXEMPTS FACILITIES THAT MANUFACTURE OXYGEN USP BY THE AIR LIQUEFACTION PROCESS FROM THE TESTS FOR CARBON DIOXIDE AND CARBON MONOXIDE.  OUR OXYGEN USP IS MANUFACTURED BY THE AIR LIQUEFACTION PROCESS

    THE METHODOLOGY BEING USED TO PERFORM THE USP/NF TEST FOR ASSAY IS INDICATED BELOW:

    PARAMAGNETIC ANALYZER  MODEL: SERVOMEX 5200

    SUPPLIER SIGNATURE:_____________________________ DATE:___________________

    OXYGEN COA

  • WARNINGS AND PRECAUTIONS

    THIS MATERIAL WAS FILLED IN ACCORDANCE WITH OUR STANDARD OPERATING PROCEDURES UTILIZED FOR THE MANUFACTURE OF MEDICAL GASES.  THESE PROCEDURES ENSURE THAT PRODUCTS ARE SAFELY MANUFACTURED IN COMPLIANCE WITH THE FDA'S CURRENT GOOD MANUFACTURING PRACTICES (cGMP) REGULATIONS AND FDA MEDICAL GAS GUIDELINES FOR MEDICAL GAS CUSTOMERS.  FOR NON-MEDICAL CUSTOMERS, THIS MATERIAL IS NOT APPROVED FOR HUMAN DRUG USE.

  • INGREDIENTS AND APPEARANCE
    OXYGEN 
    oxygen gas
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:55586-001
    Route of AdministrationRESPIRATORY (INHALATION)
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYGEN (UNII: S88TT14065) (OXYGEN - UNII:S88TT14065) OXYGEN99 L  in 100 L
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55586-001-01387367 L in 1 TANK
    2NDC:55586-001-02618485 L in 1 TANK
    3NDC:55586-001-03683589 L in 1 TANK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved medical gas01/01/1971
    Labeler - Sims Welding Supply Co, Inc. (135480783)
    Registrant - Sims Welding Supply Co, Inc. (135480783)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sims Welding Supply Co, Inc.135480783manufacture